BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR KIT X1

    MDR report key: 2990042 · Received February 5, 2013

    Report

    Report Number
    9615742-2013-00035
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    June 28, 2004
    Report Date
    June 28, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K041176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADD'L INFO FROM IMPORTER REPORT 1018233-2013-00078, 000090: ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-00078, 00090.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS IMPLANTED FOR THERAPEUTIC TREATMENT OF STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DIFFICULTY URINATING, CHRONIC VAGINAL PAIN, RECURRENCE OF CYSTOCELE, DYSPAREUNIA, STRESS URINARY INCONTINENCE, AND MESH EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47757 URETEX SUPPORT PP TRANSOBTUR KIT X1 URETEX SUPPORT FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R